# RBQM Specialist

**Company**: ICON Strategic Solutions
**Location**: Sao Paulo
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Brazil-Sao-Paulo/Clinical-Data-Risk-Manager_JR163965-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/rbqm-specialist-d34a8601-d49/

## Description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

**Job Summary:** This position reports to a Director of RBQM Operations and is responsible for successfully implementing and coordinating RBQM procedures at the study level, including initial and recurring risk identification, assessment, centralized risk monitoring, and mitigation activities within the RBQM framework.

**Responsibilities:**

- Implement RBQM procedures for assigned studies

- Review study protocol and facilitate development of the Study Risk Assessment

- Develop study-specific content and lead RBQM training and RBQM kick-off meetings

- Author and implement the study-specific RBQM plan

- Lead risk assessment meetings and engage cross-functional study team members

- Partner with the RBQM system configuration team to ensure risk indicators are programmed and functioning per operational requirements

- Perform periodic central monitoring of aggregate data to identify emerging risks and/or issues

- Lead risk review meetings and discussions with study team members

- Ensure corrective actions and preventative actions are properly documented and implemented

- Monitor the effectiveness of study risk mitigation actions and make recommendations to adjust as needed

- Create signal and trending reports for study teams

- Partner with the Adaptive Monitoring Excellence team for signals requiring review or adjustment to study level plans

- Maintain up-to-date, accurate documentation of RBQM activities

- Support and participate in internal and external audits and inspections

**Requirements:**

- Bachelor's degree in a health-related, life science area or international equivalent

- Minimum of 6 years of experience in the pharmaceutical or CRO industry

- Minimum of 2 years of experience in Risk-Based Quality Management

- Minimum of 2 years managerial and supervisory experience

- Robust understanding of the drug development process and clinical trial execution

- Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)

**Skills:**

- Experience in risk management, sponsor audits, and health authority inspections

- Knowledge of RBQM IT systems or other data analytic systems

- Demonstrated ability to analyze data, identify patterns, and make recommendations for improvement

- Demonstrated ability to effectively lead cross-functional team meetings

- Experience forming cross-functional collaborations; strong interpersonal skills

- Supports a culture of continual improvement and innovation; promotes knowledge sharing

- Ability to influence without authority

- Thinks creatively; challenges the status quo

**Benefits:**

- Competitive base salary and performance-related incentives

- Health and wellbeing programmes including medical, dental, and vision coverage

- Retirement and pension plans

- Life assurance and disability coverage

- Employee assistance programmes and wellbeing resources

- Learning and development opportunities through structured training and career pathways

For more fresh new jobs, check out [yubhub.co](https://yubhub.co/).

## Skills

### Required
- Risk-Based Quality Management
- Clinical Trials
- Regulatory Compliance
- Data Analysis
- Leadership

### Nice to have
- RBQM IT systems
- Data Analytics
- Cross-Functional Collaboration

---

Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Brazil-Sao-Paulo/Clinical-Data-Risk-Manager_JR163965-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)